NIH StrokeNet Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (UG3/UH3 Clinical Trial Optional)

Background
The NIH StrokeNet, established by the National Institute of Neurological Disorders and Stroke (NINDS), aims to facilitate the cooperation of various organizations in advancing interventions for stroke prevention, treatment, and rehabilitation.

This funding opportunity encourages applications for multi-site exploratory and confirmatory clinical trials focused on promising interventions, biomarker validation studies, and ancillary studies that enhance ongoing research within the StrokeNet framework. The goal is to conduct high-quality clinical trials that can lead to significant advancements in stroke care.

Grant Details
This NOFO supports multi-site exploratory and confirmatory clinical trials targeting promising interventions for stroke treatment, recovery, and prevention. It includes:
1. Exploratory clinical trials with defined pathways and decision points for future Phase 3 trials.
2. Biomarker or outcome measure validation studies that prepare for future trials.
3. Ancillary studies that add scientific aims to ongoing StrokeNet studies.

Successful applicants will collaborate with the NIH StrokeNet infrastructure, including the National Coordinating Center (NCC) for efficient study implementation and the National Data Management Center (NDMC) for statistical support. The NIH StrokeNet Regional Coordinating Centers (RCCs) will assist with recruitment and protocol implementation.

Eligibility Requirements
Eligible applicants include higher education institutions, nonprofits, for-profit organizations, local/state governments, tribal governments, and other entities.

Special encouragement is given to institutions serving underrepresented populations such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and others. Applicants do not need to be part of the existing NIH StrokeNet infrastructure to apply.

Period of Performance
The grant supports a two-phase project: an initial UG3 phase lasting up to one year focused on planning and protocol development, followed by a UH3 phase lasting up to six years for full trial implementation.

Grant Value
The total value of grants awarded under this NOFO is contingent upon NIH appropriations. There is no specified limit on application budgets; however, they must reflect actual project needs.

Place of Performance
The grant activities are expected to be conducted at various clinical sites affiliated with the NIH StrokeNet across the United States.